Amitava is currently a Clinical Pharmacology Leader, where he supports global drug development programs. He has 13 years of experience in the pharmaceutical industry supporting various therapeutic areas and has previously worked at Novartis and Merck.

Amitava has a PhD in Pharmaceutical Sciences from University of Maryland, Baltimore. Amitava’s main research interests include clinical pharmacology, modeling & simulation, pharmacokinetics, and biopharmaceutics. He has interacted with several regulatory agencies like FDA, EMA and PMDA on these topics, as part of project support as well as in workshops and consortia. Amitava has published more than 50 research and review articles, and has 30 podium presentations in national & international conferences, on these topics.

Amitava has been involved in several cross-industry consortia such as IMI-OrBiTo and IQ. He is also active in AAPS and ASCPT. He was the Clinical Pharmacology Track Chair on 2019 AAPS PharmSci 360 Scientific Programming Committee.

Mark Krook is Vice President, Supply Chain End-to-End Strategy, in Janssen Supply Chain’s (JSC) Value Chain Management group. In this role, Mark is responsible for orchestrating the end-to-end lifecycle management of the Therapeutic Area product portfolios in partnership with the R&D and Commercial teams.

Mark has over 30 years of drug development experience in the pharmaceutical industry. He began his career at The Upjohn Company (eventually becoming Pfizer) as a process chemist working on API process development for clinical and commercial needs, eventually moving into the leadership of global, multi-site chemical process R&D organizations with responsibilities for both laboratory and pilot plant facilities. From there he transitioned to portfolio management, providing broad technical, strategic and governance oversight for cross-functional CMC activities within a diversified portfolio of small molecule development projects.

He earned a B.A. in Chemistry from the College of St. Thomas (now University of St. Thomas) and completed a Ph.D. in Organic Chemistry from the University of Notre Dame.

Anders Brunmark obtained his undergraduate in chemistry at University of Lund and completed his PhD on quinones and free radical biochemistry at University of Linköping, Sweden. He held a faculty position at this University between 1988 and 1992. He did postdoctoral work on immune recognition at the Department of Immunology at The Scripps Research Institute in La Jolla, CA between 1990 and 1994. Anders Brunmark joined J&J’s Pharmaceutical R&D organization in 1994 as group leader for protein expression and held a group leader position in Immunology Discovery 1999-2004. In 2004 Anders established an enabling technologies team at the La Jolla, California R&D site, comprising DMPK, PharmSci/formulations, Genomics, Compound Logistics, and High Throughput Screening functions. In 2012 he took a job as Scientific Director in Integrated Systems Biology. 2014-2016 he was Director in External Innovation in Janssen R&D Discovery Sciences with primary responsibility for Western US and Canada. Since 2016 he has served as Director for Discovery Sciences Lab Ops at the La Jolla Janssen site. He is an author on 48 papers, 3 book chapters, and inventor on 5 patents.

Katherine has 30 years of progressive global regulatory experience in small and large sized Pharma companies. She has worked on products at various stages of development, from early through to filing, approval and commercialization. Katherine is the Janssen Regulatory Head of Regenerative Medicine & Advanced Therapy (RMAT). In this role, she ensures global regulatory policy strategies contribute to and support development plans for RMAT products across several therapeutic areas and facilitates J&J enterprise wide efforts to enhance awareness and connectivity for the development of processes that enable assessing, partnering, and developing safe and effective advanced therapies globally. Externally, she is the co-chair of the National Academy Science Engineering Medicine Regenerative Medicine Forum, and Advanced Therapy Industry Liaison of the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee. Katherine is an adjunct professor at Syracuse University College of Engineering and Computer Science teaching Introduction to Global Regulatory Affairs. She received her Bachelor of Science Biology from Temple University, Juris Doctorate from Widener University Law School, and is admitted to the practice of law in Pennsylvania and New Jersey.

Tony Ndifor is a project leader in Nonclinical Safety group providing toxicology expertise on early and late compound development teams. Tony has over 20 years of experience providing preclinical safety assessment expertise within drug development teams across a variety of therapeutic areas. He has previously held positions at Parke-Davis in MI, and Amgen in CA. He has broad expertise in both biologics and small molecule development, having spent about half his career on each. He completed his undergraduate and graduate education at the University of Liverpool, England. Among other professional activities, Tony is currently serving on the leadership Council for the Society of Toxicology.

Ben A. Bulthuis is responsible for Early CMC Development of antibodies and large proteins.

After receiving a BSc in Biology, then a MSc in Cell Biology and Biochemistry, Ben’s first employment was by the Free University of Amsterdam, studying the efficiency of growth and exoprotein production by bacteria. This work led to peer-reviewed publications and two book chapters.

After obtaining his PhD in Microbial Physiology he joined Genencor (now DuPont) in California, developing production processes for bacterial and fungal enzymes as well as generation of fine chemicals by microbial means. The latter led to four patents and a share in the 2009 Marvin T. Johnson Award in Microbial and Biochemical Technology from the American Chemical Society.

Ben then joined Centocor (now Janssen/J&J) in The Netherlands, executing Technical Support and Process Development & Troubleshooting, combining science & technology with Six Sigma analyses. He then moved to Pennsylvania to join Janssen R&D and has since been involved in development of Cell Culture & Purification of antibodies and other large proteins.

Within Janssen, Ben has worked through the years on commercial products and on many assets still in Development. Part of this work has led to recognition by four J&J Leadership Awards.

Dr. Subinay Ganguly is a Senior Director leading a group of scientists within BioTherapeutic Development at Janssen Research & Development. His group activities include generation of  cell lines for clinical and commercial production of protein therapeutics. He has many years of industry experience on protein expression, cell line development for production of therapeutic monoclonal and bi/tri-specific antibodies, cross-functional CMC team leaderships and external collaborations with CMOs/CROs on drug substance and drug product process development plus GMP manufacturing.  Before joining Centocor/Janssen, he worked at Bristol Myers Squibb and SmithKline Beecham (now Glaxo SmithKline) and at Yale Medical School. 

Dr. Ganguly holds a BSc in Chemistry (Honours), an MSc in Biochemistry and a PhD in Biochemistry from University of Calcutta, India. He received postdoctoral training at Albert Einstein College of Medicine and Massachusetts Institute of Technology. He is an author on numerous publications in leading scientific journals, book chapters and several patents.

Sanjay started his career as an entrepreneur at San Diego-based start-up Morphogen Pharmaceuticals, where as a Development Scientist, he established pre-clinical operations to develop cell therapies for cardiovascular and neurological indications. He then joined Johnson & Johnson where he cofounded an internal venture within Centocor to develop potential cell therapies for macular degeneration.

Sanjay received his PhD in Pharmacology and MSc In Clinical Pharmacology from The University of Aberdeen, UK and trained at Nottingham Trent University, UK in Applied Biology for his BSc. He completed post-doctoral fellowships at the University of Pittsburgh Medical School and at the Scripps Research Institute, where he worked as a postdoc in the lab of the late nobel laureate Gerald Edelman. He is the holder of 20 issued US patents and has 20 peer-reviewed publications. He is also a Life Science Kauffman Fellow of Class 14.